Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane - Study Results

Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane (TEAM)

This study has been completed.

Study NCT00036270 Information provided by Pfizer

First Received on May 8, 2002. Last Updated on September 13, 2011 History of Changes

Results First Received: October 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Breast Neoplasms
Interventions:	Drug: exemestane (Aromasin) Drug: tamoxifen + exemestane

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Exemestane	Exemestane (Aromasin®) 25 mg QD for 5 years.
Tamoxifen Followed by Exemestane	Tamoxifen 20 milligrams (mg) once daily (QD); upon completing 2.5 years to 3 years of tamoxifen, subjects were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.

Participant Flow for 2 periods

Period 1: Randomized to Study Treatment

	Exemestane	Tamoxifen Followed by Exemestane
STARTED	4904	4875
COMPLETED	4898	4868
NOT COMPLETED	6	7
Withdrawn consent	6	7

Period 2: Study Treatment to 2.75 Year Report

	Exemestane	Tamoxifen Followed by Exemestane
STARTED	4898	4868
COMPLETED	3658	3052
NOT COMPLETED	1240	1816
Treatment not started	45	51
Ineligible	130	143
Lost to Follow-up	139	188
Treatment refusal	84	179
Adverse Event	411	554
Disease recurrence	195	242
New primary tumor	20	19
Protocol Violation	17	52
Intercurrent illness	6	20
Death	75	60
Other reason or unknown	118	162
Related to treatment switch	0	146

Baseline Characteristics

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Reporting Groups

	Description
Exemestane	Exemestane (Aromasin®) 25 mg QD for 5 years.
Tamoxifen Followed by Exemestane	Tamoxifen 20 milligrams (mg) once daily (QD); upon completing 2.5 years to 3 years of tamoxifen, subjects were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.

Baseline Measures

	Exemestane	Tamoxifen Followed by Exemestane	Total
Number of Participants [units: participants]	4898	4868	9766
Age, Customized [units: participants]
<50 years	171	160	331
50 to 59 years	1509	1508	3017
60 to 69 years	1836	1895	3731
>=70 years	1382	1305	2687
Gender, Customized [units: participants]
Female	4898	4868	9766

Outcome Measures

1. Primary:

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years [ Time Frame: Baseline (Month 0) up to 2.75 years ]

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2. Primary:

Disease Free Survival [ Time Frame: 5 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Overall Survival [ Time Frame: 5 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

The Incidence of New Primary Breast Cancers of the Postmenopausal Women Treated With 5 Years of Exemestane (Aromasin) Versus Tamoxifen Therapy for 2.5- 3 Years Followed by 2.5- 2 Years of Exemestane (Aromasin). [ Time Frame: 2.75 years; 5 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Summary of Adverse Events: Overall Number of Subjects Affected for Adverse Events and Serious Adverse Events [ Time Frame: Baseline up to 5 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Data reported for Primary completion date (PCD) reporting data cut-off date 03Nov2008; report Primary outcome measure #1 and adverse events (serious and non-serious) through PCD.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided by Pfizer

Publications automatically indexed to this study:

van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31.

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00036270 History of Changes
Other Study ID Numbers:	971-ONC-0028-081, A5991026
Study First Received:	May 8, 2002
Results First Received:	October 30, 2009
Last Updated:	September 13, 2011
Health Authority:	United States: Food and Drug Administration